(262 days)
K952213, K number unknown
No
The device description and intended use clearly state that the device is a maintenance kit and a needle wrench, which are mechanical tools for cleaning and assembling a phacoemulsification handpiece. There is no mention of software, algorithms, or any computational processing that would involve AI or ML.
No.
The device is a maintenance kit and a tool for cleaning, assembling, and disassembling phacoemulsification handpieces, which are accessories to microsurgical systems used in performing phacoemulsification. It does not directly perform a therapeutic function on a patient.
No
The device is described as a maintenance kit and a wrench for cleaning, maintaining, assembling, and disassembling a Phacoemulsification Handpiece, which is used for performing phacoemulsification. It does not perform any diagnostic function.
No
The device description clearly states that the device is a "Maintenance Kit" containing "an assortment of tools" and an "individual tool," indicating physical hardware components.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that these devices are accessories to surgical systems used for performing phacoemulsification. Phacoemulsification is a surgical procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description reinforces that these are tools for cleaning, maintaining, assembling, and disassembling a surgical handpiece. This is related to the functionality of a surgical instrument, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information about a patient's health condition.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. These devices do not fit that description.
N/A
Intended Use / Indications for Use
The Storz D7120 Phaco Handbiece Maintenance Kit and the Storz D7125 Needle Wrench are intended to be used as accessories to Storz DAISY® (K854508). Storz Protegé® (K921758 and K950114). and PREMIERE® (K894278, K921460, and K946227) Microsurgical Systems for use in performing phacoemulsification. The D7120 contains an assortment of tools useful in cleaning and maintaining the Phacoemulsification Hndpiece (K935926) and the D7125 is an individual tool used in the assembly and disassembly of the handpiece.
Cleaning Ultrasonic Handpiece Immediately After Use
Product codes
HQC
Device Description
The Storz D7120 Phaco Handbiece Maintenance Kit and the Storz D7125 Needle Wrench are intended to be used as accessories to Storz DAISY® (K854508). Storz Protegé® (K921758 and K950114). and PREMIERE® (K894278, K921460, and K946227) Microsurgical Systems for use in performing phacoemulsification. The D7120 contains an assortment of tools useful in cleaning and maintaining the Phacoemulsification Hndpiece (K935926) and the D7125 is an individual tool used in the assembly and disassembly of the handpiece.
Included: Syringe, Stopcock Fluidics Connectors, Needle Wrench, Aspirator Brush.
Instrument Type: Phacoemulsification Handpiece.
Tools Provided Sterile?: No.
Tools Commonly Available Or Available From Supplier?: Yes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K952213, K number unknown
Reference Device(s)
K854508, K921758, K950114, K894278, K921460, K946227, K935926
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a sequence of numbers and a letter. The sequence starts with the letter 'K', followed by the numbers '96', '00', and '24'. The text is written in a bold, sans-serif font, and the characters are closely spaced together. The overall impression is that of a serial number or code.
Image /page/0/Picture/1 description: The image shows the word "storz" in a stylized font. The word is white and is set against a black background. There is a registered trademark symbol to the right of the word.
Premarket Notification STORZ Instrument Company
SEP 20 1996
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
Contact Person: Manager, Requlatory Affairs
Date Prepared: December 28, 1995
Proprietary Names: Storz D7120 Phaco Handpiece Maintenance Kit and Storz D7125 Needle Wrench.
Common/Usual Name: Ophthalmic microsurgical system accessories for phacoemulsification. .
Classification Name: System, Phacofragmentation (86 HQC).
Device Description/Intended Use: The Storz D7120 Phaco Handbiece Maintenance Kit and the Storz D7125 Needle Wrench are intended to be used as accessories to Storz DAISY® (K854508). Storz Protegé® (K921758 and K950114). and PREMIERE® (K894278, K921460, and K946227) Microsurgical Systems for use in performing phacoemulsification. The D7120 contains an assortment of tools useful in cleaning and maintaining the Phacoemulsification Hndpiece (K935926) and the D7125 is an individual tool used in the assembly and disassembly of the handpiece.
Predicate Device: The Storz D7120 and D7125 are substantially equivalent to similar cleaning and maintenance tools recommended by manuals for the Alcon Series 20000 ™ LEGACY " (K952213) and the AMO® Prestige ™ Advanced Cataract Extraction System™ (K number unknown) systems.
Predicate Comparison: A chart comparing the Storz D7120 and D7125 to the predicate devices demonstrating substantial equivalence, is attached.
Submitted by:
Milton Sattler
Michael H. Southworth Storz Instrument Company 3365 Tree Court Industrial Blvd. St. Louis, MO 63122 Ph. 314/225-5051
STORZ' 3365 Tree Court Industrial Blvd. St. I ouis. MO 63122-6694 (314) 225-5051 FAX (314) 225-7365
1
DEVICE COMPARISON CHART
ﺴﺴ
ﺴﺔ
| Device
Characteristic | AMO® Prestige™ | SERIES 20000®
LEGACY™ | Storz D7120 and
D7125 |
|---------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Intended Use | Cleaning Ultrasonic
Handpiece
Immediately After
Use | Cleaning Ultrasonic
Handpiece
Immediately After
Use | Cleaning Ultrasonic
Handpiece
Immediately After
Use |
| Tools Recommended
/ Included | Recommended:
Syringe, Fluidics
Connectors, Tip
Wrench | Recommended:
Syringe, Fluidics
Connectors, Tip
Wrench | Included: Syringe,
Stopcock Fluidics
Connectors, Needle
Wrench, Aspirator
Brush |
| Instrument Type | Phacoemulsification
Handpiece | Phacoemulsification
Handpiece | Phacoemulsification
Handpiece |
| Tools Provided
Sterile? | No | No | No |
| Tools Commonly
Available Or
Available From
Supplier? | Yes | Yes | Yes |